510(k) · Cleared

Cleared

Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator

K021316510(k) TraditionalCleared Jul 25, 200291-day reviewClass I21 CFR 862.1475

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Genzyme Corp. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Cleared on Jul 25, 2002 after a 91-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided: Jul 25, 2002
Review: 91 days
Class: Class I
Product code: LBS
Recalls: None
Predicates: 0

9 later devices descend from it, 7 citing it directly.

This deviceK021316 Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous…Genzyme Corp. · 2002
Descendant · cites it directly · 3 of its ownK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
Descendant · cites it directly · 0 of its ownK241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol…Siemens Healthcare Diagnostics, Inc. · 2024
Descendant · cites it directly · 0 of its ownK162593 HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo) · 2016
Descendant · cites it directly · 0 of its ownK103747 Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator…Elitechgroup Seppim S.A.S. · 2011
Descendant · 2 generations on · 0 of its ownK102993 Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems…Seppim S.A.S. · 2011

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004high 2 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 9 · See all

K060854Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · cites it directly3descendants
K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc. · 2024 · cites it directly0descendants
K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo) · 2016 · cites it directly0descendants
K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S. · 2011 · cites it directly0descendants
K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021316	Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL…	Genzyme Corp.	2002	—
+1	K060854	Abx Pentra 400: Lipoproteins	Horiba Abx	2006	2
+1	K241800	Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)	Siemens Healthcare Diagnostics, Inc.	2024	—
+1	K162593	HDL-Cholesterol Gen.4	Roche Diagnostics Operations (Rdo)	2016	—
+1	K103747	Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G…	Elitechgroup Seppim S.A.S.	2011	—
+2	K102993	Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems…	Seppim S.A.S.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2007	1	0
2008	1	0
2011	2	0
2016	1	0
2024	1	0

FIG. 1 — Lineage of K021316, 2002–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LBS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Liquid N-geneous HDL Cholesterol Reagent method Named without a submission number			—

What descends from it? (9)

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060854	Abx Pentra 400: Lipoproteins	Horiba Abx	2006	3
K241800	Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)	Siemens Healthcare Diagnostics, Inc.	2024	0
K162593	HDL-Cholesterol Gen.4	Roche Diagnostics Operations (Rdo)	2016	0
K103747	Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…	Elitechgroup Seppim S.A.S.	2011	0
K072395	Diazyme HDL-Cholesterol Reagent,Calibrator, Controls	Diazyme Laboratories	2008	0
K051962	Ultra HDL	Abbott Laboratories	2005	0
K041090	HDL-EX Seiken Assay Kit	Denka Seiken Co., Ltd.	2004	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K060854 (Horiba Abx, 2006) has gone furthest, with 3 descendants of its own.

How does its category compare?

All LBS devices

LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBS

2in 2016

2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBS

118in 2011

2007high 129 (2008) · low 118 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LBS

1in 2013

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LBS

6in 2025

2007high 6 (2025) · low 0 (2007)2025

MAUDE reports naming product code LBS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	3	129	1	0
2009	0	—	0	0
2010	2	—	0	2
2011	3	118	0	3
2012	1	—	1	0
2013	0	—	1	0
2014	1	—	0	0
2015	0	—	0	0
2016	2	—	0	1
2017	0	—	0	4
2018	0	—	0	0
2019	0	—	0	2
2020	0	—	0	1
2021	0	—	0	1
2022	0	—	0	2
2023	0	—	0	5
2024	0	—	0	2
2025	0	—	0	6
2026	0	—	0	—

What is it indicated for?

Reagent:

For the quantitative determination of high-density cholesterol lipoprotein cholesterol in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases).

Calibrator:

For calibration of the Ultra HDL Cholesterol assay.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021316 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021316: Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021316

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026